Pharmaceutical company, Merck & Co. Inc., has made it its mission for the world to see its “Gardasil- One Less” television commercials advertising the HPV vaccine- Gardasil. They consist of women vowing to be “one less” woman to get cervical cancer. They claim that getting vaccinated is an obvious choice and that good mothers must vaccinate their daughters. In the commercial, the information presented to us is that Gardasil prevents cervical cancer (Gardasil 2009).It does this by protecting us against four strains of HPV, two of which (strains 16 and 18) may lead to 70% of cervical cancers (Gardasil 2009). In other words, it doesn’t protect against all cervical cancers, only those which stem from these two strains of HPV. What the commercials fail to tell us is that there are more than 100 other strains of HPV, several of which can also lead to cancer.Having considered how little protection this vaccine may offer, Gardasil may still appear as an extra precautionary measure in the battle against cervical cancer. Fortunately, 90% of all HPV infections resolve themselves, including infections from cancer-causing strains 16 and 18.Medical Accountability Network Executive Director Dr. Moira Dolan sums up the big picture: Per one million women, the vaccination would prevent cancer in 4- 5.Of these women, only 1- 2 would die from cervical cancer.Therefore, vaccinating one million women at a cost of anywhere between $300 to $500 million would save 1- 2 lives (Dolan 2007).
HPV Vaccine History
This drug was approved by the FDA on June 8, 2006 (Fletcher 2008) – meaning it has yet to be on the market for a full 3 years! The clinical trials done prior the approval were conducted (and fast-tracked) by the pharmaceutical company (Merck & Co.) itself (Fletcher 2008). The results of these trials were vague at best. Tests were unable to show the vaccine’s effect on girls aged 9-13 – Gardasil’s target demographic (VRAN 2008).In her article, HPV Vaccine: Our Daughters are the Test Population, long-time member of the Vaccination Risk Awareness Network, Susan Fletcher states that the tests did, however, show that Gardasil increased the risk of cervical cancer by 44.6% in women who have already been exposed to the vaccine-type HPV strains (Fletcher 2008). She also found that the FDA approved this vaccine despite being fully aware of these findings (Fletcher 2008).Not only is the vaccine still permitted; it is encouraged by doctors and receiving government funding!Keep in mind, there is still no program in place to test women for HPV exposure prior to administrating the vaccine. According to the Vaccine Risk Awareness Network, only two years after Gardasil’s approval, VAERS (Vaccine Adverse Events Reporting System) documented thousands of reported reactions to the vaccine including; 105 life-threatening reactions (pulmonary embolisms, blood clots, precancerous lesions, strokes, comas, etc.); 255 hospitalizations; 1236 on-going complications (severe migraines, thyroid problems, seizures, abdominal pains, etc. ) ; 159 unresolved disabilities (paralysis, hallucinations, Bell’s palsy, etc.); 8838 other incidents (rash, fainting, genital warts, herpes, swelling at injection site, trouble breathing, etc.); and 15 deaths (VRAN 2008).These deaths include only those directly linked to Gardasil (occurring within days or weeks of vaccination) and do not include deaths that occurred months after the shot, outside the United States or those reported after July 3, 2008 (VRAN 2008). The NationalVaccineInformationCenter reports that 85 life-threatening reactions and 17 deaths occurred within Gardasil’s clinical trial alone (NVIC 2006). Trial investigators excused them, insisting they had no relation to the vaccine (NVIC 2006). Unfortunately, the long list of dangers is not yet over.In the course of their clinical trials, Gardasil did not test whether this vaccine can potentially cause birth defects, infertility or genotoxicity (Dolan 2007).So far, five children were born with birth defects to women who received the vaccine during their pregnancies (VRAN 2008).It is also unknown how long the vaccine’s protection will last, whether it may be administered with other drugs or vaccines or whether it can cause other forms of cancer (Dolan 2007).In fact, two of the vaccine’s ingredients (aluminium and polysorbate) have been linked to cancer through animal testing (VRAN 2008).As researcher journalist, Cynthia A. Janak discovers, the icing on the cake in the Gardasil concoction is sodium borate (Janak 2008).Used in detergents and rat poison, its Hazards Identification Profile reads “WARNING! HARMFUL IF SWALLOWED, INHALED OR ABSORBED THROUGH SKIN. CAUSES IRRITATION TO SKIN, EYES AND RESPIRATORY TRACT” (Janak 2008). We have to ask ourselves – whereas 1-2 lives may be saved for every million girls who receive the vaccine (Dolan 2007), how many girls will become paralyzed, suffer seizures and endure the very disease the vaccine was meant to prevent – how many of them will die?
Merck & Co. Pharmaceutical
Ladies, meet your maker – pharmaceutical company, Merck & Co., Inc.Although their current target demographic is too young to remember, some older generations may remember Merck’s financial downfall after its Vioxx disaster.As The New York Times journalist, Stephanie Saul reminds us, in 2004, Merck issued a recall on its prescription painkiller, Vioxx, after it was found responsible for ca vast amount of heart attacks and strokes (Saul 2008).She reports that after thousands of lawsuits and a $4.85 billion settlement, an investigation into Merck’s clinical trials for Vioxx revealed that the pharmaceutical giant had ghostwritten the majority of the drug’s clinical studies (Saul 2008).Rather than being lead by a reputable doctor, Vioxx clinical trials were lead by Merck employees who then submitted final reports under the signature of a prestigious doctor (Saul 2008).In the few years following the Vioxx recall, Merck became increasingly reckless with its products.In July 2007, Merck recalled Invanz, an injectable antibiotic for children due to broken glass in the product (Adverse Events Reporting News 2007).In August of 2007, Merck failed to list possible side effects of allergy medicine, Singulair, leading to Cody Miller’s suicide within two weeks of his first dose (Bauchus & Schanker, LLC 2008).In December of 2007, Merck recalled PedvacHIB and Comavax, children’s vaccines for Haemophilus influenza type B, Haemophilus B and hepatitis B due to sterility problems (Richwine et al. 2007).In November 2008, it recalled Mylicon Gas Relief Dye-Free Drops due to metal fragments in the product (U.S. Food and Drug Administration 2008). Merck has on-going lawsuits for patients using Fasomax, a treatment for bone loss and osteoporosis as it leads to osteonecrosis of the jaw (or dead jaw) (Johnson 4 May 2008).Finally, in 2008, the FDA warned Merck about the objectionable state of their plant in West Point, Pennsylvania (Johnson 30 Apr. 2008).The letter raised concerns about the plant’s irresponsible distribution of vaccines that failed visual inspection, as well as their inability to ensure a drug’s identity, strength or purity (Johnson 30 Apr. 2008).This plant also produces Gardasil (Johnson 30 Apr 2008). Despite bad publicity for their Vioxx trials and drug recalls, Merck is at it again.The NationalVaccineInformationCenter confirms that Merck did not use a regular non-reactive placebo in its clinical trials for Gardasil (NVIC 2006).Instead, Merck injected the control group with a placebo that contained aluminium (NVIC 2006) – a reactive metal that poisons the body as it accumulates in bones and the central nervous system (Janak 2008).This manipulates the results of the trials by mimicking the adverse reactions of the Gardasil group in the control group, thus limiting the number of additional side-effects experienced by the Gardasil group (NVIC 2006).Curiously, the FDA gave Merck permission to do this, yet neither disclosed this information to the public (NVIC 2006).
The Stakeholders
The main stakeholder in this situation is Merck & Co. Inc. This pharmaceutical company is the only party to have conducted trials to make sure that the vaccine is safe, as such, they fast-tracked and altered the trials to get the desired results. At $300- $500 per vaccination, this appears to be the “cash cow” that Merck has been waiting for since the Vioxx lawsuits.The Food and Drug Administration is in a delicate position because it approved a potentially dangerous vaccine despite its questionable trial results (NVIC 2006). Undoubtedly, the women being vaccinated are taking the largest risk in this situation.By striking guilt in mothers and fear in their daughters, Merck’s widespread advertising campaign targets its demographic emotionally.This distracts many women from researching the facts.
The HPV Vaccine: An Exposé
By Justyna PaszkiewiczThe HPV Vaccine
Pharmaceutical company, Merck & Co. Inc., has made it its mission for the world to see its “Gardasil- One Less” television commercials advertising the HPV vaccine- Gardasil. They consist of women vowing to be “one less” woman to get cervical cancer. They claim that getting vaccinated is an obvious choice and that good mothers must vaccinate their daughters. In the commercial, the information presented to us is that Gardasil prevents cervical cancer (Gardasil 2009). It does this by protecting us against four strains of HPV, two of which (strains 16 and 18) may lead to 70% of cervical cancers (Gardasil 2009). In other words, it doesn’t protect against all cervical cancers, only those which stem from these two strains of HPV. What the commercials fail to tell us is that there are more than 100 other strains of HPV, several of which can also lead to cancer. Having considered how little protection this vaccine may offer, Gardasil may still appear as an extra precautionary measure in the battle against cervical cancer. Fortunately, 90% of all HPV infections resolve themselves, including infections from cancer-causing strains 16 and 18. Medical Accountability Network Executive Director Dr. Moira Dolan sums up the big picture:
Per one million women, the vaccination would prevent cancer in 4- 5. Of these women, only 1- 2 would die from cervical cancer. Therefore, vaccinating one million women at a cost of anywhere between $300 to $500 million would save 1- 2 lives (Dolan 2007).
HPV Vaccine History
This drug was approved by the FDA on June 8, 2006 (Fletcher 2008) – meaning it has yet to be on the market for a full 3 years! The clinical trials done prior the approval were conducted (and fast-tracked) by the pharmaceutical company (Merck & Co.) itself (Fletcher 2008). The results of these trials were vague at best. Tests were unable to show the vaccine’s effect on girls aged 9-13 – Gardasil’s target demographic (VRAN 2008). In her article, HPV Vaccine: Our Daughters are the Test Population, long-time member of the Vaccination Risk Awareness Network, Susan Fletcher states that the tests did, however, show that Gardasil increased the risk of cervical cancer by 44.6% in women who have already been exposed to the vaccine-type HPV strains (Fletcher 2008). She also found that the FDA approved this vaccine despite being fully aware of these findings (Fletcher 2008). Not only is the vaccine still permitted; it is encouraged by doctors and receiving government funding! Keep in mind, there is still no program in place to test women for HPV exposure prior to administrating the vaccine.According to the Vaccine Risk Awareness Network, only two years after Gardasil’s approval, VAERS (Vaccine Adverse Events Reporting System) documented thousands of reported reactions to the vaccine including; 105 life-threatening reactions (pulmonary embolisms, blood clots, precancerous lesions, strokes, comas, etc.); 255 hospitalizations; 1236 on-going complications (severe migraines, thyroid problems, seizures, abdominal pains, etc. ) ; 159 unresolved disabilities (paralysis, hallucinations, Bell’s palsy, etc.); 8838 other incidents (rash, fainting, genital warts, herpes, swelling at injection site, trouble breathing, etc.); and 15 deaths (VRAN 2008). These deaths include only those directly linked to Gardasil (occurring within days or weeks of vaccination) and do not include deaths that occurred months after the shot, outside the United States or those reported after July 3, 2008 (VRAN 2008). The National Vaccine Information Center reports that 85 life-threatening reactions and 17 deaths occurred within Gardasil’s clinical trial alone (NVIC 2006). Trial investigators excused them, insisting they had no relation to the vaccine (NVIC 2006).
Unfortunately, the long list of dangers is not yet over. In the course of their clinical trials, Gardasil did not test whether this vaccine can potentially cause birth defects, infertility or genotoxicity (Dolan 2007). So far, five children were born with birth defects to women who received the vaccine during their pregnancies (VRAN 2008). It is also unknown how long the vaccine’s protection will last, whether it may be administered with other drugs or vaccines or whether it can cause other forms of cancer (Dolan 2007). In fact, two of the vaccine’s ingredients (aluminium and polysorbate) have been linked to cancer through animal testing (VRAN 2008). As researcher journalist, Cynthia A. Janak discovers, the icing on the cake in the Gardasil concoction is sodium borate (Janak 2008). Used in detergents and rat poison, its Hazards Identification Profile reads “WARNING! HARMFUL IF SWALLOWED, INHALED OR ABSORBED THROUGH SKIN. CAUSES IRRITATION TO SKIN, EYES AND RESPIRATORY TRACT” (Janak 2008).
We have to ask ourselves – whereas 1-2 lives may be saved for every million girls who receive the vaccine (Dolan 2007), how many girls will become paralyzed, suffer seizures and endure the very disease the vaccine was meant to prevent – how many of them will die?
Merck & Co. Pharmaceutical
Ladies, meet your maker – pharmaceutical company, Merck & Co., Inc. Although their current target demographic is too young to remember, some older generations may remember Merck’s financial downfall after its Vioxx disaster. As The New York Times journalist, Stephanie Saul reminds us, in 2004, Merck issued a recall on its prescription painkiller, Vioxx, after it was found responsible for ca vast amount of heart attacks and strokes (Saul 2008). She reports that after thousands of lawsuits and a $4.85 billion settlement, an investigation into Merck’s clinical trials for Vioxx revealed that the pharmaceutical giant had ghostwritten the majority of the drug’s clinical studies (Saul 2008). Rather than being lead by a reputable doctor, Vioxx clinical trials were lead by Merck employees who then submitted final reports under the signature of a prestigious doctor (Saul 2008). In the few years following the Vioxx recall, Merck became increasingly reckless with its products. In July 2007, Merck recalled Invanz, an injectable antibiotic for children due to broken glass in the product (Adverse Events Reporting News 2007). In August of 2007, Merck failed to list possible side effects of allergy medicine, Singulair, leading to Cody Miller’s suicide within two weeks of his first dose (Bauchus & Schanker, LLC 2008). In December of 2007, Merck recalled PedvacHIB and Comavax, children’s vaccines for Haemophilus influenza type B, Haemophilus B and hepatitis B due to sterility problems (Richwine et al. 2007). In November 2008, it recalled Mylicon Gas Relief Dye-Free Drops due to metal fragments in the product (U.S. Food and Drug Administration 2008). Merck has on-going lawsuits for patients using Fasomax, a treatment for bone loss and osteoporosis as it leads to osteonecrosis of the jaw (or dead jaw) (Johnson 4 May 2008). Finally, in 2008, the FDA warned Merck about the objectionable state of their plant in West Point, Pennsylvania (Johnson 30 Apr. 2008). The letter raised concerns about the plant’s irresponsible distribution of vaccines that failed visual inspection, as well as their inability to ensure a drug’s identity, strength or purity (Johnson 30 Apr. 2008). This plant also produces Gardasil (Johnson 30 Apr 2008).
Despite bad publicity for their Vioxx trials and drug recalls, Merck is at it again. The National Vaccine Information Center confirms that Merck did not use a regular non-reactive placebo in its clinical trials for Gardasil (NVIC 2006). Instead, Merck injected the control group with a placebo that contained aluminium (NVIC 2006) – a reactive metal that poisons the body as it accumulates in bones and the central nervous system (Janak 2008). This manipulates the results of the trials by mimicking the adverse reactions of the Gardasil group in the control group, thus limiting the number of additional side-effects experienced by the Gardasil group (NVIC 2006). Curiously, the FDA gave Merck permission to do this, yet neither disclosed this information to the public (NVIC 2006).
The Stakeholders
The main stakeholder in this situation is Merck & Co. Inc. This pharmaceutical company is the only party to have conducted trials to make sure that the vaccine is safe, as such, they fast-tracked and altered the trials to get the desired results. At $300- $500 per vaccination, this appears to be the “cash cow” that Merck has been waiting for since the Vioxx lawsuits. The Food and Drug Administration is in a delicate position because it approved a potentially dangerous vaccine despite its questionable trial results (NVIC 2006). Undoubtedly, the women being vaccinated are taking the largest risk in this situation. By striking guilt in mothers and fear in their daughters, Merck’s widespread advertising campaign targets its demographic emotionally. This distracts many women from researching the facts.
References
1. Adverse Event Reporting News. "Merck recalls some vials of Invanz following reports of broken glass." Article Archives. 16 July 2007. 30 Jan. 2009 <http://www.articlearchives.com/pharmaceuticals-biotechnology/pharmaceuticals/8797111.html>.
2. Bauchus & Schanker, LLC. "Oops they did it again. Merck’s asthma drug Singulair under investigation for suicide link by FDA." Weblog post. Legal Blog. 5 May 2008. 30 Jan. 2009 <http://www.coloradolaw.net/blog/misc/oops-they-did-it-again-merck-866115/>.
3. Dolan, Moira T. "Gardasil: Not SO Miraculous." HPV Truth Articles. 2007. 30 Jan. 2009
<http://www.hpvtruth.org/articles/gardasil_not_miraculous.html>.
4. Fletcher, Susan. "HPV Vaccine: Our Daughters are the Test Population March 2008." VRAN. 31 July 2008. Vaccine Risk Awareness Network. 30 Jan. 2009 <www.vran.org/vaccines/hpv/VRAN_Susan%20Fletcher_HPV%20Vaccine%20analysis_2008-07-31.pdf>.
5. "Gardasil- One Less." Advertisement. Gardasil.com. 30 Jan. 2009 <http://www.gardasil.com/i-chose-tv/>.
6. Janak, Cynthia A. "Gardasil vaccine -- poison or cure." Renew America 6 Apr. 2008. 30 Jan. 2009 <http://www.renewamerica.us/columns/janak/080406>.
7. Johnson, Linda A. "Streak of trouble with FDA, other problems hits Merck." USA Today 4 May 2008. 30 Jan. 2009 <http://www.usatoday.com/money/economy/2008-05-04-1677956314_x.htm>.
8. Johnson, Linda A. "FDA warns Merck to fix vaccine plant problems." USA Today 30 Apr. 2008. 30 Jan. 2009 <http://www.usatoday.com/money/economy/2008-04-30-357466359_x.htm>.
9. National Vaccine Information Center (NVIC). "MERCK'S GARDASIL VACCINE NOT PROVEN SAFE FOR LITTLE GIRLS." Press release. NVIC. 27 June 2006. National Vaccine Information Center. 30 Jan. 2009 <http://www.nvic.org/PressReleases/pr62706gardasil.htm>.
10. Richwine, Lisa, Maggie Fox, and Lisa Baertlein. "Merck recalls 1.2 mln doses of children's vaccines." National Post 12 Dec. 2007. 30 Jan. 2009 <http://www.nationalpost.com/life/health/story.html?id=5984d591-c046-48af-a892-a7afbe94787e&k=56904&p=2>.
11. Saul, Stephanie. "Ghostwriters Used in Vioxx Studies, Article Says." The New York Times 15 Apr. 2008. 30 Jan. 2009 <http://www.nytimes.com/2008/04/15/business/15cnd-vioxx.html?ei=5088&>.
12. U.S. Food And Drug Administration. U.S. Department of Health and Human Services. "Johnson and Johnson--Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments." Press release. Recall--Firm Press Release. 7 Nov. 2008. 30 Jan. 2009 <http://www.fda.gov/oc/po/firmrecalls/johnsonjohnson11_08.html>.
13. VRAN. "HPV (Human Papilloma Virus) & Cervical Cancer Vaccine: Merck's Gardasil®." VRAN. 2008. Vaccine Risk Awareness Network. 30 Jan. 2009 <http://www.vran.org/vaccines/hpv/hpv.htm>.
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